Updates on 503A Compounding: Legal and Regulatory Developments by Martha Rumore in Pharmacy Times

Pharmacy compounding is a vital aspect of pharmacy practice, playing a crucial role in healthcare provision. However, there have been several recent legal and regulatory developments regarding 503A pharmacy compounding, presenting both opportunities and challenges for the industry. Frier Levitt pharmacist-attorney Martha M. Rumore published part 1 of a two-part series in Pharmacy Times where she explores USP <797> and <795> revisions for sterile and nonsterile compounding, veterinary compounding, FDA inspections of 503A pharmacies, and the interstate distribution of compounding prescriptions post Wellness Pharmacy v. FDA. Part 2 will review the compounding of drugs on the FDA shortage list, compounding “essentially a copy,” compounding peptides, DTE, semaglutide, β lactams, ibuprofen, and bHRT.

Read article HERE.